Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is an analysis using the French national health insurance database, six months after the beginning of NOAC launch in the NVAF indication.
The aim is to compare the one-year, two-year and three-year benefit-risk (major bleeding, arterial thrombotic events, myocardial infarction (MI), death) between patients starting a NOAC and patients starting a VKA for NVAF in 2013
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOAC | New oral anticoagulant groups | ||
| VKA | VKA group |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Clinically Relevant Bleeding | First hospitalization with primary diagnosis (Tenth Revision codes of the International Classification of Diseases (ICD-10 codes)) of:
| One year |
| Major Bleeding | First hospitalization with primary diagnosis (ICD-10 codes) of:
| 1 year |
| Arterial Thrombotic Event | First hospitalization with primary diagnosis (ICD-10 codes) of:
| 1 year |
| Acute Coronary Syndrome | First hospitalization with primary diagnosis (ICD-10 codes) of:
| One year |
| Death (All-cause) | All-cause death (cause of death not available in the database). | 1 year |
| Composite Criterion (Clinically Relevant Bleeding, Arterial Thrombotic Events, Acute Coronary Syndrome, Death) | First event among clinically relevant bleeding, arterial thrombotic event, acute coronary syndrome, or death defined above. | One year |
Not provided
Not provided
Inclusion criteria:
Patients with NVAF with a first reimbursed dispensation of Pradaxa®, Xarelto®, or VKA in 2013, with no other identified indication for anticoagulation; Without any VKA or NOAC (Pradaxa®, Xarelto®, or Eliquis®) reimbursed dispensation for the last 3 years before the first reimbursed dispensation of Pradaxa®, Xarelto®, or VKA
Exclusion criteria:
None
Not provided
Not provided
Not provided
New users of NOAC or VKA for NVAF
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1160.263.1 Boehringer Ingelheim Investigational Site | Multiple Locations | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31254174 | Derived | Blin P, Dureau-Pournin C, Benichou J, Cottin Y, Mismetti P, Abouelfath A, Lassalle R, Droz C, Moore N. Comparative Real-Life Effectiveness and Safety of Dabigatran or Rivaroxaban vs. Vitamin K Antagonists: A High-Dimensional Propensity Score Matched New Users Cohort Study in the French National Healthcare Data System SNDS. Am J Cardiovasc Drugs. 2020 Feb;20(1):81-103. doi: 10.1007/s40256-019-00359-z. | |
| 30499605 |
Not provided
Not provided
The main objective was to compare the risk & effectiveness for dabigatran vs VKA, & for rivaroxaban vs VKA. The main analysis was done for hdPS matched patients (pts.) with atrial fibrillation (AF) diagnosis information in the database.
The study ENGEL 2 is a real-world historical cohort study in the French nationwide healthcare claims and hospitalization database (SNIIRAM) including new users of DOAC or VKA for nonvalvular atrial fibrillation (NVAF) in 2013 with a follow-up for one year (main objective).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran | Patients with a first dispensing of dabigatran in 2013 for NVAF. |
| FG001 | Rivaroxaban | Patients with a first dispensing of rivaroxaban in 2013 for NVAF. |
| FG002 | Vitamin K Antagonists | Patients with a first dispensing of VKA in 2013 for NVAF. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran | Patients with a first dispensing of dabigatran in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS. |
| BG001 | Rivaroxaban |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinically Relevant Bleeding | First hospitalization with primary diagnosis (Tenth Revision codes of the International Classification of Diseases (ICD-10 codes)) of:
| Patients (pts) with a first dispensing (dispen.) of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks (wks.)), gender, age at index date (± 1 year (yr)) and high-dimensional propensity score (hdPS, ± 0.05). | Posted | Number | participants with event | One year |
|
Not provided
Claims and hospitalization database without any adverse event declaration, and using secondary individual anonymous information. Thus all outcomes studied were reported in aggregate in the final study report.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dabigatran | Patients with a first dispensing of dabigatran in 2013 for NVAF. |
Not provided
Not provided
DOAC & VKA were prescribed by physicians in their daily practice,with differences for pts & disease characteristics,including stroke & bleeding risk factors.To control this pts were 1:1 matched on date of 1st dispensing, gender,age & hdPS.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
| Derived |
| Blin P, Dureau-Pournin C, Cottin Y, Benichou J, Mismetti P, Abouelfath A, Lassalle R, Droz C, Moore N. Comparative Effectiveness and Safety of Standard or Reduced Dose Dabigatran vs. Rivaroxaban in Nonvalvular Atrial Fibrillation. Clin Pharmacol Ther. 2019 Jun;105(6):1439-1455. doi: 10.1002/cpt.1318. Epub 2019 Feb 6. |
Patients with a first dispensing of rivaroxaban in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
| BG002 | Vitamin K Antagonists | Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex/Gender, Customized | The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA. | Count of Participants | Participants |
|
| OG001 | VKA (Dabigatran vs VKA) | Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS. |
| OG002 | Rivaroxaban (Rivaroxaban vs VKA) | Patients with a first dispensing of rivaroxaban in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS. |
| OG003 | VKA (Rivaroxaban vs VKA) | Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS. |
|
|
|
| Primary | Major Bleeding | First hospitalization with primary diagnosis (ICD-10 codes) of:
| Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05). | Posted | Number | participants with events | 1 year |
|
|
|
|
| Primary | Arterial Thrombotic Event | First hospitalization with primary diagnosis (ICD-10 codes) of:
| Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05). | Posted | Number | participants with events | 1 year |
|
|
|
|
| Primary | Acute Coronary Syndrome | First hospitalization with primary diagnosis (ICD-10 codes) of:
| Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05). | Posted | Number | participants with events | One year |
|
|
|
|
| Primary | Death (All-cause) | All-cause death (cause of death not available in the database). | Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05). | Posted | Number | participants with events | 1 year |
|
|
|
|
| Primary | Composite Criterion (Clinically Relevant Bleeding, Arterial Thrombotic Events, Acute Coronary Syndrome, Death) | First event among clinically relevant bleeding, arterial thrombotic event, acute coronary syndrome, or death defined above. | Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05). | Posted | Number | participants with events | One year |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Rivaroxaban | Patients with a first dispensing of rivaroxaban in 2013 for NVAF. | 0 | 0 | 0 | 0 |
| EG002 | Vitamin K Antagonists | Patients with a first dispensing of VKA in 2013 for NVAF. | 0 | 0 | 0 | 0 |
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
|
|
| Female |
|
|
|
Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk). |
| Fine and Gray model |
| <0.0001 |
| Hazard Ratio (HR) |
| 0.68 |
| 2-Sided |
| 95 |
| 0.58 |
| 0.79 |
| Superiority or Other |
Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk). |
| Fine and Gray model |
| 0.8341 |
| Hazard Ratio (HR) |
| 0.98 |
| 2-Sided |
| 95 |
| 0.85 |
| 1.14 |
| Superiority or Other |
Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk). |
| Fine and Gray model |
| 0.0501 |
| Hazard Ratio (HR) |
| 0.84 |
| 2-Sided |
| 95 |
| 0.71 |
| 1.00 |
| Superiority or Other |
Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI. |
| Cox proportional hazard risk model |
| <0.0001 |
| Hazard Ratio (HR) |
| 0.77 |
| 2-Sided |
| 95 |
| 0.71 |
| 0.84 |
| Superiority or Other |
Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI. |
| Cox proportional hazard risk model |
| <0.0001 |
| Hazard Ratio (HR) |
| 0.84 |
| 2-Sided |
| 95 |
| 0.79 |
| 0.89 |
| Superiority or Other |